RELEASE OF INFORMATION Monsanto is submitting the information in this petition for review by the USDA as part of the regulatory process. By submitting this information, Monsanto does not authorize its release to any third party. In the event the USDA receives a Freedom of Information Act request, pursuant to 5 U.S.C. § 552, and 7 CFR Part 1, covering all or some of this information, Monsanto expects that, in advance of the release of the document(s), USDA will provide Monsanto with a copy of the material proposed to be released and the opportunity to object to the release of any information based on appropriate legal grounds, e.g. responsiveness, confidentiality, and/or competitive concerns. Monsanto expects that no information that has been identified as CBI (confidential business information), will be provided to any third party. Monsanto understands that a CBI- deleted copy of this information may be made available to the public in a reading room and by individual request, as part of a public comment period. Except in accordance with the foregoing, Monsanto does not authorize the release, publication or other distribution of this information (including website posting) without Monsanto's prior notice and consent. 2009 Monsanto Company. All Rights Reserved. This document is protected under copyright law. This document is for use only by the regulatory authority to which this has been submitted by Monsanto Company, and only in support of actions requested by Monsanto Company. Any other use of this material, without prior written consent of Monsanto, is strictly prohibited. By submitting this document, Monsanto does not grant any party or entity any right to license or to use the information or intellectual property described in this document. Monsanto Company 09-SY-194U Page 2 of 338 EXECUTIVE SUMMARY The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has responsibility under the Plant Protection Act (7 USC § 7701- 7772) to prevent the introduction and dissemination of plant pests into the United States. APHIS regulation 7 CFR § 340.6 provides that an applicant may petition APHIS to evaluate submitted data to determine that a particular regulated article does not present a plant pest risk and should no longer be regulated. If APHIS determines that the regulated article does not present a plant pest risk, the petition is granted, thereby allowing unrestricted introduction of the article. Monsanto Company is submitting this request to APHIS for a determination of non- regulated status in whole for the new biotechnology-derived insect-protected soybean product, MON 87701, any progeny derived from crosses between MON 87701 and conventional soybean, and any progeny derived from crosses of MON 87701 with other biotechnology-derived soybean that has been granted non-regulated status under 7 CFR Part 340. Product Description Monsanto Company has developed biotechnology-derived insect-protected soybean MON 87701 that produces the Cry1Ac insecticidal crystal (Cry) protein ( δ-endotoxin) derived from Bacillus thuringiensis (Bt) subsp. kurstaki . The Cry1Ac protein provides protection from feeding damage caused by targeted lepidopteran pests. The cry1Ac gene was transferred into the genome of soybean cells using Agrobacterium tumefaciens- mediated transformation. The MON 87701 product concept is to reduce or replace current insecticide applications to control lepidopteran pests in tropical and subtropical soybean production regions where these insects cause significant plant damage and yield loss. MON 87701 will offer growers in these regions an effective pest management tool and help to maintain soybean yield potential. Soybean production in the U.S. can be impacted by insect pests that require insecticide treatments to control infestations that reach economic thresholds. The impact and severity of insect pest infestations vary greatly across soybean production regions primarily due to the different climate and weather conditions, insect species distributions, insect species environmental tolerances, and agricultural practices. In the U.S., the most economically important soybean lepidopteran pests are the defoliating and pod-feeding insects. The most damaging lepidopteran defoliators are velvetbean caterpillar, Anticarsia gemmatalis ; soybean looper, Pseudoplusia includens ; and green cloverworm, Plathypena scabra . Analysis of Cry1Ac protein levels in over-season leaf indicate that relatively high levels of the Cry1Ac protein are expressed throughout the entire growing season in MON 87701, providing exceptional control of targeted lepidopteran pests, such as velvetbean caterpillar ( Anticarsia gemmatalis ) and soybean looper ( Pseudoplusia includens). In general, insect pressure is greatest on soybean grown in the southern U.S., especially the southeastern states bordering the Gulf of Mexico and Atlantic Ocean, in which the tropical and sub-tropical weather favors pest infestation. According to USDA- NASS statistics, about 16% of the approximately 75 million U.S. soybean acres, those Monsanto Company 09-SY-194U Page 4 of 338 grown mainly in the southeastern and delta states, received insecticide applications in 2006 (USDA-NASS, 2007b). Given the limited number of acres in the U.S. that consistently have sufficient lepidopteran insect pressure to require the use of insecticides or other insect control practices, Monsanto will file an application with the EPA to support future breeding and seed multiplication activities in the U.S. This application will request a seed increase registration of the plant-incorporated protectant Bacillus thuringiensis Cry1Ac protein and the genetic material (vector PV-GMIR9) necessary for its production in soybean. Under this type of seed increase registration, commercial sale of MON 87701 within the U.S. would be prohibited by law. In the future, if Monsanto decides to commercially introduce MON 87701 in the U.S., Monsanto would be required to apply to the EPA for a commercial use registration of the plant-incorporated protectant Bacillus thuringiensis Cry1Ac protein and the genetic material (vector PV-GMIR9) necessary for its production in soybean. As a condition of a commercial use registration, EPA would require that Monsanto develop, administer, and oversee an EPA-approved insect resistance monitoring (IRM) program. EPA does not require IRM programs for the small acreages used for Section 3 seed increase registrations. Data and Information Presented to Assess Plant Pest Potential of MON 87701 The data and information presented in this Petition demonstrate the familiarity of MON 87701 as compared to conventional soybean and, moreover, show that MON 87701 is not likely to pose an increased plant pest potential, including weediness or adverse environmental impact, compared to conventional soybean. The overall safety of MON 87701 was confirmed based on multiple, well established lines of evidence: 1. A detailed molecular characterization of the inserted DNA, where the results confirm the insertion of a single functional cry1Ac expression cassette at a single locus within the soybean genome. 2. An extensive set of biochemical evaluations that demonstrate the identity of the full-length Cry1Ac produced in MON 87701. 3. An assessment of toxicity and allergenicity potential of the Cry1Ac protein based on extensive information collected and evaluations performed on Cry1Ac. The results demonstrate that the Cry1Ac protein is not likely to be a toxin or allergen. 4. The compositional and nutritional assessment confirmed that MON 87701 harvested seed and forage are compositionally and nutritionally equivalent to and as safe as those of conventional soybean. 5. An extensive evaluation of the MON 87701 phenotypic and agronomic characteristics and environmental interactions that demonstrate MON 87701 is not likely to have increased plant pest potential compared to conventional soybean. 6. An assessment on the potential impact to non-target-organisms (NTOs) and endangered species concludes that MON 87701 is unlikely to have adverse effects on these organisms under normal agricultural practices. Monsanto Company 09-SY-194U Page 5 of 338 Weediness Potential of Soybean The commercial soybean species in the U.S. ( Glycine max L.) does not exhibit weedy characteristics and is not effective in invading established ecosystems. Soybean is not listed as a weed in major weed references (Crockett, 1977; Holm et al., 1979; Muenscher, 1980), nor is it present on the lists of noxious weed species distributed by the federal government (7 CFR Part 360). Soybean does not possess any of the attributes commonly associated with weeds (Baker, 1965), such as long persistence of seed in the soil, the ability to disperse, invade, and become a dominant species in new or diverse landscapes, or the ability to compete well with native vegetation. Due to the lack of dormancy, soybean seed can germinate quickly under adequate temperature and moisture and potentially can grow as a volunteer plant. However, a volunteer plant likely would be killed by frost during autumn or winter of the year it was produced. If it did become established, a volunteer plant would not compete well with the succeeding crop, and could be controlled readily by either mechanical or chemical means (OECD, 2000). In addition, since wild populations of Glycine species are not known to exist in the U.S., the potential does not exist for MON 87701 to outcross to wild or weedy relatives and alter their weediness potential.